BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARSTEM MODULAR HEAD FOR 21000662

    MDR report key: 15244573 · Received August 17, 2022

    Report

    Report Number
    9613369-2022-00471
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    July 28, 2022
    Report Date
    November 14, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    LXH
    UDI-DI
    07611996114393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: IT WAS REPORTED THAT, A POLARSTEM MODULAR HEAD FOR 2100066 WAS GOUGED AND CHIPPING PLASTIC OFF. AS THIS WAS NOTICED AFTER A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE PATIENT WAS NOT INVOLVED. THE COMPLAINT DEVICE INTENDED FOR USE IN TREATMENT WAS RETURNED FOR INVESTIGATION. A VISUAL EVALUATION OF THE RETURNED DEVICE WAS CONDUCTED, AND IT WAS CONCLUDED THAT THE SURFACE OF THE DEVICE IS HEAVILY DEFORMED WITH BURRS AND SCRATCHES, HOWEVER, THERE IS NO VISIBLE FRACTURES. SO, THE MENTIONED FAILURE MODE IS CONFIRMED. A REVIEW OF THE PRODUCTION DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE PERFORMED COMPLAINT HISTORY REVIEW FOR THE COMPLAINT DEVICE REVEALED 4 ADDITIONAL COMPLAINTS REPORTED FOR THE SAME BATCH. HOWEVER, NONE OF THESE COMPLAINTS SHOW A SIMILAR FAILURE MODE. A REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE, OCCURRENCE AND SEVERITY OF THE REPORTED ISSUE. POLARSTEM MODULAR HEAD FOR IMPACTOR (750023711) IS DESIGNED TO IMPACT A BALL HEAD ON THE POLARSTEM TAPER. PREVIOUS INVESTIGATION SHOWED THAT WHILE USING THE MODULAR HEAD AS INTENDED, THE PRESENT FAILURE MODE CANNOT BE REPRODUCED. HOWEVER, THE FAILURE MODE COULD BE REPRODUCED BY SIMULATING AN OFF-LABEL USE. THEREFORE, THE ROOT CAUSE IS ATTRIBUTED TO AN OFF-LABEL USE OF THE DEVICE. THERE ARE NO INDICATIONS THAT THIS FAILURE IS RELATED TO ANY MANUFACTURING ISSUES. TO DATE, FURTHER ACTIONS ARE NOT DEEMED NECESSARY. THERE IS NO INDICATION THAT THE REPORTED DEVICES FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. ACCORDING TO DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH & NEPHEW ORTHOPAEDICS AG" (LIT. N°03389-EN 1363 V3 11/19), ALL DEVICES MUST BE INSPECTED AND CONTROLLED FOR PROPER FUNCTIONING AFTER CLEANING/DISINFECTION. NEVERTHELESS, SMITH+NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THE RETURNED DEVICE WILL BE DISCARDED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT, A POLARSTEM MODULAR HEAD FOR 2100066 WAS GOUGED AND CHIPPING PLASTIC OFF. AS THIS WAS NOTICED AFTER A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE PATIENT WAS NOT INVOLVED. THE DEVICE INTENDED FOR USE IN TREATMENT WAS NOT RETURNED FOR FURTHER INVESTIGATION. NO VISUAL INSPECTION COULD BE PERFORMED. A COMPLAINT HISTORY REVIEW WAS PERFORMED. THE CURRENT COMPLAINT IS IN LINE WITH THE COMPLAINT REVIEW ON PART LEVEL. DUE TO INSUFFICIENT INFORMATION IT IS NOT POSSIBLE TO PERFORM A REVIEW OF PAST CORRECTIVE ACTIONS. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE AND SEVERITY OF THE REPORTED ISSUE. THE REVIEW OF THE PRODUCTION DOCUMENTATION COULD NOT BE PERFORMED DUE TO MISSING BATCH NUMBER. A RELATIONSHIP BETWEEN THE REPORTED EVENTS AND THE DEVICE CANNOT BE CONFIRMED. BASED ON THE PERFORMED INVESTIGATIONS, THE FAILURE MODES OF THE REPORTED ISSUES COULD NOT BE CONFIRMED AND THE ROOT CAUSE OF THE REPORTED PROBLEMS REMAIN UNKNOWN. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENTS. ACCORDING TO DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH & NEPHEW ORTHOPAEDICS AG" (LIT. N°03389-EN 1363 V3 11/19), ALL DEVICES MUST BE INSPECTED AND CONTROLLED FOR PROPER FUNCTIONING AFTER CLEANING/DISINFECTION. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SMITH AND NEPHEW WILL CONTINUE TO MONITOR THE DEVICE FOR SIMILAR ISSUES. THIS INVESTIGATION IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE POLARSTEM BALL HEAD IMPACTOR WAS GOUGED AND CHIPPING PLASTIC OFF. AS THIS WAS NOTICED AFTER A TKA PROCEDURE, THE PATIENT WAS NOT INVOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, A POLARSTEM MODULAR HEAD FOR 2100066 WAS GOUGED AND CHIPPING PLASTIC OFF. AS THIS WAS NOTICED AFTER A TKA PROCEDURE, THE PATIENT WAS NOT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522289 POLARSTEM MODULAR HEAD FOR 21000662 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW ORTHOPAEDICS AG 75023710 UNKNOWN 07611996114393
    1542802 POLARSTEM MODULAR HEAD FOR 21000662 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW ORTHOPAEDICS AG 75023710 UNKNOWN 07611996114393

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown